PREDNISOLONE SODIUM PHOSPHATE solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

متاح من:

Pharmaceutical Associates, Inc.

INN (الاسم الدولي):

PREDNISOLONE SODIUM PHOSPHATE

تركيب:

PREDNISOLONE 20 mg in 5 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Prednisolone Sodium Phosphate Oral Solution (20 mg prednisolone base per 5 mL) is indicated in the following conditions: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenit

ملخص المنتج:

Each 5 mL (teaspoonful) of grape flavored solution contains 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base). NDC 0121-0777-08:  8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2°-8°C (36°-46°F). Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R09/2018

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
----------
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION
(20 MG PREDNISOLONE BASE PER 5 ML)
RX ONLY
DESCRIPTION
Prednisolone Sodium Phosphate Oral Solution (20 mg prednisolone base
per 5 mL) is a
dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of
Prednisolone Sodium
Phosphate Oral Solution contains 26.9 mg prednisolone sodium phosphate
(20 mg
prednisolone base) in a palatable, aqueous vehicle.
Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution (20
mg prednisolone
base per 5 mL) contains the following inactive ingredients:
anti-bitter mask, high
fructose corn syrup, edetate disodium, glycerin, grape flavor,
hydroxyethylcellulose,
methylparaben, potassium phosphate dibasic, potassium phosphate
monobasic, purified
water, and sodium saccharin.
Prednisolone sodium phosphate occurs as white or slightly yellow,
friable granules or
powder. It is freely soluble in water; soluble in methanol; slightly
soluble in alcohol and in
chloroform; and very slightly soluble in acetone and in dioxane. The
chemical name of
prednisolone sodium phosphate is
pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-
(phosphonooxy)-disodium salt, (11β)-. The empirical formula is C
H
Na
O
P; the
molecular weight is 484.39. Its chemical structure is:
PHARMACOLOGICAL CATEGORY: GLUCOCORTICOID
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone), which also have
salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their
synthetic analogs are primarily used for their potent
anti-inflammatory effects in
disorders of many organ systems.
21
27
2
8
Prednisolone is a synthetic adrenocortical steroid drug with
predominantly glucocorticoid
properties.
Some of these properties reproduce the physiological actions of
endogenous
glucocorticosteroids, but others do not necessarily reflect any of the
adrenal hormones’
normal functions; they are seen only after administrat